EzRay Air (Model VEX-P300)
FDA 510(k) K161063 · VATECH Co., Ltd.
510(k) numberK161063
Submission
- Device name
- EzRay Air (Model VEX-P300)
- Applicant
- VATECH Co., Ltd.
Hwaseong-Si, KR - Received
- April 15, 2016
- Decision date
- September 1, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K210329 | Green X 18(Model : PHT-75CHS)OAS · Special | 02/18/2021SE |
| K203667 | EzRay M (Model: VMX-P300)IZL · Traditional | 02/02/2021SE |
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Questions and answers
When was EzRay Air (Model VEX-P300) cleared by the FDA?
EzRay Air (Model VEX-P300) (K161063) received a 510(k) decision of Substantially Equivalent on September 1, 2016, 139 days after the submission was received.
What is the product code of K161063?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.